Datascope Passport - Mindray

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Appendix Performance Specifications 6.2.11.2 Masimo ® Pulse Rate Performance Pulse Rate During No Motion Conditions 4 : Adult/Pediatric/Neonates: 30 to 235 bpm ± 3 digits Pulse Rate During Motion Conditions 2,3 : Adult/Pediatric/Neonates: 30 to 235 bpm ± 5 digits Update Rate: Every 2 seconds 1 The Masimo MS-3 pulse oximeter with LNOP ® Adt sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 2 ® The Masimo MS-3 pulse oximeter with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 3 ® ® The Masimo MS-3 pulse oximeter with LNOP Neo and LNOP NeoPt sensors has been validated for motion accuracy in human blood studies on neonates while moving the neonates foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 4The Masimo MS-3 pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturation’s ranging from 70% to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 5 The LNOP Ear Sensors have an SpO2 accuracy of 70% to 100% ± 3.5 for adults during no motion conditions, however, since the monitor cannot display 1/2 digits, the accuracy shall be rounded to ± 4 digits. 6 The SpO2 accuracy during motion conditions is not specified for the LNOP Ear Sensors. Passport 2®/Passport 2 LT Operating Instructions 0070-10-0649-01 6 - 19
Performance Specifications Appendix 6.2.11.3 Nellcor SpO 2 Performance Requirements Complies with the following Nellcor specifications: 046095 Rev. C. (MP304 OEM product specification) 068107 Rev. D/1 (NELL-3 OEM product specification) Sensor Compatibility: Nellcor types: D-25/D-25L, R-15, N-25, I-20, D-20, RS-10, OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I, Oxiband A/N, Oxiband P/I, DS-100A, DY-S, Max-Fast Measurement Technique: Nellcor proprietary algorithm. Saturation Accuracy Patient Size Range Adult 70% to 100%, ± 2 digits Adult Below 70%, unspecified Neonate 70% to 100%, ± 3 digits Neonate Below 70%, unspecified SpO 2 Response Time: 5 to 7 seconds averaging 6.2.11.4 Nellcor SpO 2 Pulse Rate Performance Requirements Pulse Rate Range: 20 to 249 bpm Pulse Rate Accuracy: ± 3 bpm Update Rate: Every 2 seconds 6 - 20 0070-10-0649-01 Passport 2®/Passport 2 LT Operating Instructions
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Datascope Passport® Datascope Pass
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CapnoLine and NIV Line are tradem
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Table of Contents “ECG Lead Fault
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Table of Contents NIBP Accessories.
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Table of Contents Newborn NIBP Tech
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Introduction Warnings Warnings WARN
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Introduction Warnings WARNING: Use
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Introduction Precautions Precaution
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Introduction Precautions CAUTION: T
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Introduction Intended Use Intended
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Introduction Symbols and Descriptio
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General Description The Mindray DS
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General Description Communication w
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Front Panel Controls, Indicators an
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Front Panel Controls, Indicators an
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Display Controls, Indicators and Co
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Display Controls, Indicators and Co
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Menus Controls, Indicators and Conn
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Left Side Panel Controls, Indicator
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Rear Panel Controls, Indicators and
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Gas Module (Optional Passport 2) Co
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Gas Module (Optional Passport 2) Co
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Comm-Port (Optional Passport 2) Con
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Comm-Port (Optional Passport 2) Con
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Getting Started Operation NOTE: Pat
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Installation Mode Operation The fol
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Installation Mode Operation 3.2.2 S
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Non-Invasive Blood Pressure Measure
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ECG Measurements Operation 3.4.1.2
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ECG Measurements Operation Standard
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ECG Measurements Operation Lead II
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ECG Measurements Operation Neonatal
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ECG Measurements Operation 3.4.2 Th
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ECG Measurements Operation CAUTION:
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Invasive Blood Pressure (IBP1, IBP2
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SpO 2 Pulse Oximetry Operation CAUT
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SpO 2 Pulse Oximetry Operation 3.6.
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ST Monitoring (Optional Passport 2)
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Arrhythmia Algorithm (Optional Pass
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Arrhythmia Algorithm (Optional Pass
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Arrhythmia Alarms (Optional Passpor
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Arrhythmia Alarms (Optional Passpor
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Arrhythmia Analysis (Optional Passp
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Temperature Menu Operation 3.12 Tem
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List Trends (Passport 2 Only) Opera
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Graph Trends (Passport 2 Only) Oper
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Graph Trends (Passport 2 Only) Oper
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OXY CRG Display Menu (Passport 2 on
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Respiration Monitoring Operation Th
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Microstream ® CO 2 Monitoring (Opt
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Microstream ® CO 2 Monitoring (Opt
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Gas Module (optional Passport 2) Op
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Alarms Operation 3.19.2 Alarm Limit
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Alarms Operation 3.19.4 Alarm Viola
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Alarms Operation MUTE - This key is
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Recorder (Optional) Operation 3.20
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Recorder (Optional) Operation Trend
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Recorder (Optional) Operation The c
Page 131 and 132: Laser Printing 12 Lead ECG (optiona
Page 133 and 134: Status Messages Operation 3.22.2 Sp
Page 135 and 136: Status Messages Operation MESSAGE R
Page 137 and 138: Status Messages Operation MESSAGE R
Page 139 and 140: Monitor Problem Solving Operation P
Page 141 and 142: Connection to Visa or PatientNet Ce
Page 143 and 144: Connection to Panorama Gateway Ope
Page 145 and 146: Decontamination of Monitor User Mai
Page 147 and 148: Recorder Paper Replacement User Mai
Page 149 and 150: Care and Cleaning of Gas Module Use
Page 151 and 152: Care and Cleaning of View 12 ECG C
Page 153 and 154: Optional Accessories Accessories Di
Page 155 and 156: Optional Accessories Accessories DE
Page 157 and 158: Optional Accessories Accessories DE
Page 159 and 160: Optional Accessories Accessories 5.
Page 161 and 162: Optional Accessories Accessories 5.
Page 163 and 164: Optional Accessories Accessories Th
Page 165 and 166: Safety Designations Appendix Degree
Page 167 and 168: Performance Specifications Appendix
Page 181: Performance Specifications Appendix
Page 193 and 194: Environmental Conditions Appendix 6
Page 195 and 196: Electromagnetic Capability Appendix
Page 203 and 204: Precautions While Making Automatica
Page 205 and 206: Warranty Appendix 6.11 Warranty 6.1
Page 207 and 208: 0070-10-0649-01 Rev J August 12, 20
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Datascope Passport - Mindray

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